Regulatory Affairs Project Manager

Regulatory Affairs Project Manager in Biotechnology in Gsap
Company Description
Gsap is an international consulting firm for healthcare companies, providing end-to-end services throughout the life cycle of medical products. Founded in 2009 by Sigalit Ariely-Portnoy, PhD, Gsap leads complex projects in the healthcare industry. The company aims to enhance the development of healthcare companies and empower them to achieve therapeutic solutions for patients worldwide.
The position will include clients’ regulatory support through product development, preparation and submission of regulatory files for various applications and programs.
דרישות התפקיד
Requirements:
M.Sc. or Ph.D. degree in Life Sciences
Proven regulatory experience of at least 5 years working with leading regulatory authorities, preferably in Regulatory Affairs managerial positions
Early-Mid clinical stage products
Experience with combination products – an advantage
Profound understanding in product development and diverse CMC subjects – an advantage
English at mother tongue level